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Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acu…
FDA 510(k)Class II (US FDA 510(k))
510(k) K131845
by Acumed, LLC
Identifiers
- 510(k) Number
- K131845 FDA 510(k)
- FDA Product Code
- KWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3170 FDA 510(k)
- Regulation Number
- 888.3170 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acu… by Acumed, LLC — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131845 | Class II | Active |
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Manufacturer
- Manufacturer
- Acumed, LLC
Sources (1)
- FDA 510(k) K131845 24 fields · synced Jun 18, 2026